Preliminary findings suggest patients with multiple sclerosis who are taking cladribine can mount and maintain effective vaccine responses.
New data indicate that patients with relapsing multiple sclerosis (RMS) who are treated with cladribine (Mavenclad; EMD Serono) tablets may achieve protective antibody responses to common vaccines.
The findings from the MAGNIFY-MS study were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2021, being held virtually February 25 to 27, 2021.
Cladribine was approved by the FDA in March 2019 as the first and only short-course oral therapy for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease. Cladribine’s US label states that all immunizations should be administered according to recommended guidelines prior to starting treatment with cladribine.
“Understanding vaccine efficacy in MS patients is particularly important in the face of the current pandemic and the growing availability of COVID-19 vaccines,” Klaus Schmierer, professor of neurology at Queen Mary University of London and The Royal London Hospital, UK, said in a statement. “Whilst this new information is based on a small cohort of patients receiving influenza and varicella zoster vaccines, it provides physicians with preliminary evidence that patients taking Mavenclad are able to mount and maintain effective vaccine responses.”
For the retrospective analysis, investigators evaluated the protective antibody response to seasonal influenza and varicella zoster virus (VZV) vaccination in patients taking cladribine. Blood samples were taken before and after vaccination.
According to the results, in patients who received the seasonal flu vaccine, protective antibody levels were maintained or increased for at least 6 months independent of lymphocyte counts measured at the time of vaccination in year 1 or 2 of cladribine treatment. Among patients who received the VZV vaccine before year 1 initiation of cladribine, protective VZV antibody levels were maintained over 6 months post-initiation with cladribine, despite lymphocyte depletion. Overall, the results were consistent irrespective of when the patients received the vaccine relative to their treatment.
Results of the CLOCK-MS vaccine sub-study analysis showed that 3 patients with RRMS who had received at least 1 dose of cladribine prior to receiving a flu vaccine had increased protective antibody levels at 4 weeks post vaccination. Two of these patients, who had received cladribine 2 and 4 months prior to vaccination, were experiencing lymphopenia around the time of vaccination.